BEUDAMED
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    PURESPERM 40 AND PURESPERM 80

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00262131·

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964019461·Endo Carry-On Procedure Kit

    Medical Facets NC

    FDA UDI
    MEDICAL FACETS NC LLC·M933MDF20026230·3.0mm Cannulated Screw, Self-Drilling, Short Th...

    SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SCULPTURE FLOW

    FDA 510(k)
    FDA Class 2 ·Dental

    TECNIS SIMPLICITY

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·September 25, 2024

    UNKNOWN DEPUY SROM SLEEVE

    FDA Adverse Event
    Injury ·DEPUY (IRELAND) 9616671·Product code JDI·March 13, 2013

    SENSOR ENLITE

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OZO·August 12, 2014

    COBAS INTEGRA 800

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·February 8, 2008

    TECNIS SIMPLICITY

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·September 25, 2024

    EB215, VOYANT MARYLAND FUSION 37CM, 6/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code GEI·November 3, 2023

    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024